AccessGUDID - DEVICE: ETHICON (10705031051034)

GUDID

Device Identifier (DI) Information

Brand Name: ETHICON
Version or Model: U10T
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: U10T
Company Name: ETHICON, LLC

Primary DI Number: 10705031051034
Issuing Agency: GS1
Commercial Distribution End Date: October 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 079402290 *Terms of Use

Device Description: Cotton Umbilical Tape

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:	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?
13983	Umbilical cord tape	A thin, flat strip of synthetic and/or natural material which is used as a tie or suture around the umbilical cord of a newborn infant after severance from the placenta. It typically consists of a braided strip of cotton thread and or spun polyester yarn and comes in a variety of sizes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FOD	DEVICE, OCCLUSION, UMBILICAL

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1f930668-d6cd-4a68-82f9-03d98bc4298d
Public Version Date: October 30, 2023
Public Version Number: 4
DI Record Publish Date: September 24, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20705031051031	24	10705031051034	2023-10-30	Not in Commercial Distribution	BOX

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: +1(877)384-4266
Email: xxx@xxx.xxx

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