AccessGUDID - DEVICE: V. Mueller (10885403058691)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: MO1280
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MO1280
Company Name: STERIS CORPORATION

Primary DI Number: 10885403058691
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021599373 *Terms of Use

Device Description: HURD TONSIL DISSECTOR and PILLAR RETRACTOR OVERALL LENGTH 8-3/4 inches22.2CM

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":	No
For Single-Use:	No
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?
33452	Tonsil dissector, reusable	A hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used during the dissection of the tonsils during ear/nose/throat (ENT) surgery. It can be designed in several configurations, e.g., with a shaft that terminates at the distal end with a rounded, curved or angled tip, or it may be double-ended. The tip may be pointed, flat, sharp or blunt and angled or straight from the shaft and may or may not be serrated. It is made of high-grade stainless steel, available in various shapes and sizes, and may include suction capabilities. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KBM	DISSECTOR, TONSIL

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7d632f02-9fda-4e6d-9c81-4296a1510acb
Public Version Date: August 19, 2024
Public Version Number: 4
DI Record Publish Date: September 05, 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
No Package DIs found

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: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)548-4873
Email: xx@xx.xx

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES