AccessGUDID - DEVICE: Henry Schein (00304040000571)

GUDID

Device Identifier (DI) Information

Brand Name: Henry Schein
Version or Model: 100-5597
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 100-5597
Company Name: HENRY SCHEIN, INC.

Primary DI Number: 00304040000571
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 012430880 *Terms of Use

Device Description: SILK SPOOL 4/0 100YD

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?
34601	Silk suture, non-sterile	A non-sterile, single-strand (monofilament), natural, non-bioabsorbable thread made from raw silk spun by silkworms intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it must be sterilized before use and may include an attached needle intended to be disposed of after single use. It provides temporary wound support until the wound sufficiently heals to withstand normal stress. Although classified as a "non-bioabsorbable" material, it is typically digested by proteolysis after an extended period of time. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GAP	SUTURE, NONABSORBABLE, SILK

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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
Special Storage Condition, Specify: N/A

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 3-0 USP

Device Record Status

Public Device Record Key: bdd1dff9-7743-4640-bc9b-b3087eda3461
Public Version Date: November 11, 2024
Public Version Number: 4
DI Record Publish Date: September 25, 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
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

[?]

No Customer Contact currently defined

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