AccessGUDID - DEVICE: RETRACTOR (00888118022653)

GUDID

Device Identifier (DI) Information

Brand Name: RETRACTOR
Version or Model: 15-975-06-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KLS-Martin L.P.

Primary DI Number: 00888118022653
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 826499238 *Terms of Use

Device Description: RIBBON, MARTIN, MALLEABLE, 6.5 MM BLADE

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?
36293	Abdominal/intestinal spatula	A hand-held manual surgical instrument designed to manipulate the intestines and organs of the abdomen during a surgical intervention in the abdominal cavity. It typically consists of a large, flat, blunt blade (no sharp edges) at the distal end and a strong handle at the proximal end. It is usually made of high-grade stainless steel and is available with a variety of blade designs (e.g., curved and flat or straight and flat with a rounded end, or right-angled); some blade types may have a serrated surface to help retain the slippery abdominal tissues. The handle is typically designed to provide a non-slip grip. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAD	RETRACTOR

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
Device Size Text, specify: 20 CM

Device Record Status

Public Device Record Key: 4326b8e2-bea2-4337-ac68-c1522a836d34
Public Version Date: August 27, 2024
Public Version Number: 4
DI Record Publish Date: September 26, 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(904)641-7746
Email: KLS-UDI-Info@klsmartin.com

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