AccessGUDID - DEVICE: E.M Adams co, inc. (18100013401463)

GUDID

Device Identifier (DI) Information

Brand Name: E.M Adams co, inc.
Version or Model: 14-3328-1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: E.M. ADAMS, INC.

Primary DI Number: 18100013401463
Issuing Agency: GS1
Commercial Distribution End Date: February 28, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 001403807 *Terms of Use

Device Description: SINGLE INSTRUMENT

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
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?
61478	Surgical soft-tissue manipulation forceps, scissors-like, single-use	A hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues; it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. 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 single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FSM	Tray, Surgical, Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K812133	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 8" X 12" BAG/ROCHESTER PEAN FORCEPS, CURVED

Device Record Status

Public Device Record Key: 0d689006-b287-443a-a74a-8e2e9b9d080f
Public Version Date: March 01, 2021
Public Version Number: 3
DI Record Publish Date: December 25, 2019