AccessGUDID - DEVICE: GIJaw (00816734021644)

GUDID

Device Identifier (DI) Information

Brand Name: GIJaw
Version or Model: 1190-03
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1190-03
Company Name: DIVERSATEK HEALTHCARE, INC.

Primary DI Number: 00816734021644
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 030650113 *Terms of Use

Device Description: GIJaw Single-Use Biopsy Forceps with Needle

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38711	Flexible endoscopic biopsy forceps, single-use	A flexible, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., gastro-urological endoscopy, laparoscopy, bronchoscopy, laryngoscopy) for histopathological examination. It is typically a flexible metal coil with a pair of scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FCL	Forceps, Biopsy, Non-Electric

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Keep away from sunlight
Storage Environment Temperature: between -10 and 40 Degrees Celsius
Storage Environment Humidity: between 30 and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 86 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
Length: 180 Centimeter
Width: 2.3 Millimeter

Device Record Status

Public Device Record Key: 578e9142-8b07-4ee2-b240-558e0bd651b0
Public Version Date: March 22, 2019
Public Version Number: 2
DI Record Publish Date: August 01, 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
10816734021641	10	00816734021644		In Commercial Distribution	case

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 800-558-6408
Email: sales@diversatekhc.com

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