AccessGUDID - DEVICE: OrthoMesh (20886982255935)

GUDID

Device Identifier (DI) Information

Brand Name: OrthoMesh
Version or Model: 803.605.02S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 80360502S
Company Name: Synthes GmbH

Primary DI Number: 20886982255935
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 486711679 *Terms of Use

Device Description: 1.5MM RESORBABLE CORTEX SCREW 5MM FOR ORTHOMESH-STERILE

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?
45039	Bioabsorbable orthopaedic bone screw	A small, threaded, implantable rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). There are several kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded. A "lag screw" can be any of these used to obtain compression across bone fragments.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HRS	PLATE, FIXATION, BONE
HWC	Screw, fixation, bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K073115	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
Handling Environment Temperature: less than 110 Degrees Fahrenheit
Storage Environment Temperature: between 5 and 25 Degrees Celsius
Handling Environment Temperature: less than 43 Degrees Celsius
Special Storage Condition, Specify: .
Storage Environment Temperature: between 41 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 312cc5db-569f-4aeb-9441-634783eee853
Public Version Date: January 03, 2024
Public Version Number: 6
DI Record Publish Date: September 14, 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
HIBCC	H67980360502S0

Unit of Use DI

[?]

Unit of Use DI Number: 80886982255937 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(800)255-2500
Email: xx@xx.xx

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