ROG Cuff Anchor 10-1301

GUDID 00855152006048

ROG 5.5mm Cuff Anchor w 3 x #2 UHMWPE suture

Rog Sports Medicine, Inc.

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID00855152006048
NIH Device Record Key1f02109c-f632-4682-b815-dd069b2e2fb0
Commercial Distribution StatusIn Commercial Distribution
Brand NameROG Cuff Anchor
Version Model Number10-1301
Catalog Number10-1301
Company DUNS006254430
Company NameRog Sports Medicine, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100855152006048 [Primary]
GS110855152006045 [Package]
Package: Box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBIFastener, Fixation, Nondegradable, Soft Tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-23
Device Publish Date2021-03-15

Devices Manufactured by Rog Sports Medicine, Inc.

00855152006048 - ROG Cuff Anchor2021-03-23ROG 5.5mm Cuff Anchor w 3 x #2 UHMWPE suture
00855152006048 - ROG Cuff Anchor2021-03-23 ROG 5.5mm Cuff Anchor w 3 x #2 UHMWPE suture
10855152006038 - RoG Rope2019-02-07 UHMWPE #2 Suture
00855152006000 - RoG Cuff Anchor 5.5mm 2018-07-06 5.5mm suture anchor with 2x 36" UHMWPE #2 suture
10855152006014 - RoG 5.5mm Knotless Suture Anchor2018-07-06 RoG 5.5mm Knotless Suture Anchor
10855152006021 - RoG Single2018-07-06 2.9mm Suture Anchor with 2x 36" UHMWPE #2 suture

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