AccessGUDID - DEVICE: Henry Schein (00304040060421)

GUDID

Device Identifier (DI) Information

Brand Name: Henry Schein
Version or Model: 1066150
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1066150
Company Name: HENRY SCHEIN, INC.

Primary DI Number: 00304040060421
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 012430880 *Terms of Use

Device Description: SPLIT SURG. BALL HOOK .021

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?
63379	Orthodontic power arm/lock	An orthodontic device in the shape of a straight pin or hook designed to accept an elastic band, power chain, spring, or archwire (not included), which apply a force in addition to the main orthodontic archwire, for vertical alignment and/or horizontal positioning of the teeth; it also includes a base that functions as an orthodontic lock/stop. The device is crimped, soldered or screwed on an orthodontic attachment (e.g., bracket, archwire) or the surface of a tooth. This is a single-patient device intended to be used for the duration of treatment (single-use) before being discarded.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
ECN	CLAMP, WIRE, ORTHODONTIC

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
No Device Sizes

Device Record Status

Public Device Record Key: 9687a19b-d241-4f8b-b3de-7e5294ae1216
Public Version Date: February 14, 2020
Public Version Number: 1
DI Record Publish Date: February 06, 2020

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: 10304040060428 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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