AccessGUDID - DEVICE: E.M Adams co, inc. (50840200304783)

GUDID

Device Identifier (DI) Information

Brand Name: E.M Adams co, inc.
Version or Model: 3030
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: E.M. ADAMS, INC.

Primary DI Number: 50840200304783
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001403807 *Terms of Use

Device Description: UNIVERSAL KNEE SPLINT

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:	No
Prescription Use (Rx):	No
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?
37470	Padded stays splint, reusable	A non-sterile padded device designed to immobilize and protect an injured body extremity (arm or leg) during the healing process. It is in the form of a preshaped rigid mould (with padding) intended to be held in place with straps/bandages (not included); it is not primarily intended for use in an emergency setting and is not intended for chronic/long-term use after healing. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HSP	Splint, Traction

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 27" X22" X20" BODY/2" X 22" STRAP

Device Record Status

Public Device Record Key: 4202edff-c2e6-4f0d-a6c7-6e3ddb51eff1
Public Version Date: December 13, 2021
Public Version Number: 1
DI Record Publish Date: December 04, 2021

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(772)461-0532
Email: EMADAMS@EMADAMSCO.COM

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