AccessGUDID - DEVICE: ENDOPEARL (20845854013578)

GUDID

Device Identifier (DI) Information

Brand Name: ENDOPEARL
Version or Model: C8059
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C8059
Company Name: Conmed Corporation

Primary DI Number: 20845854013578
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: ENDOPEARL 9MM, SOFT TISSUE FIXATION DEVICE

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?
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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K984171	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: KEEP DRY

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 9 Millimeter

Device Record Status

Public Device Record Key: 098873a3-4eaf-4686-9890-89a5d9e577f6
Public Version Date: March 21, 2019
Public Version Number: 5
DI Record Publish Date: September 24, 2016

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: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)237-0169
Email: CUSTOMER_SERVICE@CONMED.COM

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