161-00-30

GUDID 10885862033390

GUIDE TIP, CALCAR PLANER

Exactech, Inc.

Bone-resection orthopaedic reamer, reusable

Primary Device ID	10885862033390
NIH Device Record Key	7b2b4daf-aa28-47e2-970f-c7e473a5c7c2
Commercial Distribution Status	In Commercial Distribution
Version Model Number	161-00-30
Catalog Number	161-00-30
Company DUNS	157565946
Company Name	Exactech, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862033390 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K042842

FDA Product Code

LWJ	Prosthesis, hip, semi-constrained, metal/polymer, uncemented

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-08-05
Device Publish Date	2022-07-28

Devices Manufactured by Exactech, Inc.

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10885862650467 - Truliant	2025-02-28 Special LBS III Femoral Paddle Extension, Right
10885862636416 - Truliant	2025-02-07 Special Extended Femoral IM Rod
10885862636423 - Truliant	2025-02-07 Special Extended Femoral IM Rod
10885862636430 - Truliant	2025-02-07 Special Extended Femoral IM Rod Slap Hammer Adapter
10885862653260 - Truliant	2025-01-16 Special Universal Baseplate Tibial Trial, Size 1
10885862653277 - Truliant	2025-01-16 Special Universal Baseplate Tibial Trial, Size 2
10885862653284 - Truliant	2025-01-16 Special Universal Baseplate Tibial Trial, Size 3

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