9mm Washer 0.9mm Height 300-0901

GUDID 00810074300353

9mm Washer 0.9mm Height

Osteocentric Technologies, Inc.

Implantable bone washer
Primary Device ID00810074300353
NIH Device Record Key44f1ec4b-1860-4a60-85b8-1db288c6e47d
Commercial Distribution StatusIn Commercial Distribution
Brand Name9mm Washer 0.9mm Height
Version Model Number300-0901
Catalog Number300-0901
Company DUNS089645059
Company NameOsteocentric Technologies, 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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1800-969-0639
Emailinfo@osteocentric.com
Phone1800-969-0639
Emailinfo@osteocentric.com
Phone1800-969-0639
Emailinfo@osteocentric.com
Phone1800-969-0639
Emailinfo@osteocentric.com
Phone1800-969-0639
Emailinfo@osteocentric.com
Phone1800-969-0639
Emailinfo@osteocentric.com
Phone1800-969-0639
Emailinfo@osteocentric.com
Phone1800-969-0639
Emailinfo@osteocentric.com
Phone1800-969-0639
Emailinfo@osteocentric.com
Phone1800-969-0639
Emailinfo@osteocentric.com
Phone1800-969-0639
Emailinfo@osteocentric.com
Phone1800-969-0639
Emailinfo@osteocentric.com
Phone1800-969-0639
Emailinfo@osteocentric.com
Phone1800-969-0639
Emailinfo@osteocentric.com
Phone1800-969-0639
Emailinfo@osteocentric.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100810074300353 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTNWasher, Bolt Nut

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810074300353]

Moist Heat or Steam Sterilization

[00810074300353]

Moist Heat or Steam Sterilization

[00810074300353]

Moist Heat or Steam Sterilization

[00810074300353]

Moist Heat or Steam Sterilization

[00810074300353]

Moist Heat or Steam Sterilization

[00810074300353]

Moist Heat or Steam Sterilization

[00810074300353]

Moist Heat or Steam Sterilization

[00810074300353]

Moist Heat or Steam Sterilization

[00810074300353]

Moist Heat or Steam Sterilization

[00810074300353]

Moist Heat or Steam Sterilization

[00810074300353]

Moist Heat or Steam Sterilization

[00810074300353]

Moist Heat or Steam Sterilization

[00810074300353]

Moist Heat or Steam Sterilization

[00810074300353]

Moist Heat or Steam Sterilization

[00810074300353]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-26
Device Publish Date2025-05-16

Devices Manufactured by Osteocentric Technologies, Inc.

00810074307536 - 6.0 x 55mm Bone Screw Fastener ST2025-10-06 6.0 x 55mm Bone Screw Fastener ST
00810074307543 - 6.0 x 60mm Bone Screw Fastener ST2025-10-06 6.0 x 60mm Bone Screw Fastener ST
00810074307550 - 6.0 x 65mm Bone Screw Fastener ST2025-10-06 6.0 x 65mm Bone Screw Fastener ST
00810074308984 - 11 X 75mm LAG FASTENER2025-09-30 11 X 75mm LAG FASTENER
00810074309974 - 11 X 80mm LAG FASTENER2025-09-30 11 X 80mm LAG FASTENER
00810074309981 - 11 X 85mm LAG FASTENER2025-09-30 11 X 85mm LAG FASTENER
00810074309998 - 11 X 90mm LAG FASTENER2025-09-30 11 X 90mm LAG FASTENER
00810189110007 - 11 X 95mm LAG FASTENER2025-09-30 11 X 95mm LAG FASTENER
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