AccessGUDID - DEVICE: OSTEORAPTOR / ULTRABRAID (03596010615527)

GUDID

Device Identifier (DI) Information

Brand Name: OSTEORAPTOR / ULTRABRAID
Version or Model: 72201991
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 72201991
Company Name: Smith & Nephew, Inc.

Primary DI Number: 03596010615527
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045483575 *Terms of Use

Device Description: OSTEORAPTOR 2.3 W 1UB II BLUE

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
45061	Tendon/ligament bone anchor, bioabsorbable	A bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that can be chemically degraded and typically absorbed via natural body processes (e.g., a copolymer, metal alloy).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MAI	FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
HWC	Screw, fixation, bone
JDR	STAPLE, FIXATION, BONE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151105	000

Device Exempt from Premarket Submission: No 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: 7cc0a1e5-47cb-4887-be91-3611d6fb3079
Public Version Date: September 29, 2023
Public Version Number: 8
DI Record Publish Date: September 21, 2015