DEVICE: BV Medical (00845821027030)
Device Identifier (DI) Information
BV Medical
80-510-214-OTO-L
In Commercial Distribution
BV Medical
80-510-214-OTO-L
In Commercial Distribution
BV Medical
Combo Kit: Pink Breast Cancer Awareness Nurse Kit: 30-510-214 Gem-Scope, Adult, Pink, Latex Free, Breast Cancer Chest piece: 60-840-210-HP 2.5 V Standard Otoscope w/specula: 60-402-210-1 Penlight, Disposable, Pink, With Pupil Gauge, Single: 8-380J Fiberglass Tape Measure, BV Logo Sticker, White Case: 80-170-310 Utility scissors 5.5", stainless steel with neon pink handle: 80-001-210 Pink Paper Mate Write For Hope Pen - Black Ink: 80-174-000 Kelly forceps, 5.5", straight, stainless steel: Nurse Kit Pocket Organizer, White, Latex Free: 2 Velcro Tab, Fuchsia, Latex Free
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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11791 | Dressing/utility forceps, scissors-like, reusable |
A hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.
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Active | false |
12849 | Otoscope, direct |
An electrically-powered, hand-held device designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. It consists of a main unit (commonly referred to as the head) with a built-in light source intended to illuminate the interior of the ear canal with a detachable cone-shaped tube (speculum) inserted in the ear canal; it may facilitate the application of air pressure for pneumatic otoscopy. A dedicated power supply handpiece and/or an insufflation bulb may be included with the head.
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Active | false |
38832 | Hand-held examination/treatment light |
A small hand-held battery-powered light intended to beused as a personal light source to provide light for local examination, inspection, and treatment of the patient. It may be torch-like in design and can have a magnifying lens to augment the lighting effect. It will typically be found in an examination room, doctor's office, on a medical trolley, in an emergency kit, or carried in a pocket. This is a reusable device.
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Active | false |
13755 | Mechanical external stethoscope |
A non-powered, external listening device designed to be placed on the patient’s skin to listen sounds from the arms, heart, lungs, and/or gastrointestinal tract. It typically comprises a membrane at the listening head connected by a split "Y" tube to the headgear with ear olives that are placed into the user’s ears. This is a reusable device.
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Active | false |
38727 | General-purpose surgical scissors, reusable |
A hand-held manual surgical instrument designed to cut/dissect a variety of tissues during open surgery and having no dedication to a specific anatomy or clinical use; it might in addition be intended for cutting materials associated with surgery (e.g., sutures). It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed; some types may have blades that cross over to expose a sharp edge for slicing tissue like a scalpel. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. This is a reusable device.
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Active | false |
37743 | Tape measure, reusable |
A flexible, manual, non-electronic device intended to be used in a clinical setting to establish an accurate measurement of length greater than a standard ruler (e.g., the circumference of a patient's waist or thigh, or length of a leg). It is typically made of oilcloth or pliable steel and marked in units of length (i.e., inches and/or millimetres). It is usually available as a roll which may be encased in a holder. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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GEN | Forceps, General & Plastic Surgery |
ERA | Otoscope |
KYT | Light, Examination, Medical, Battery Powered |
LDE | Stethoscope, Manual |
LRW | Scissors, General, Surgical |
FTY | Tape, Measuring, Rulers And Calipers |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
91ac1265-6d9e-4f36-a0af-606dbe75e6bf
November 25, 2024
7
October 02, 2018
November 25, 2024
7
October 02, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(888)822-8293
info@bvmedical.com
info@bvmedical.com