Re-entry Base

GUDID 00853190008871

JACE MEDICAL, LLC

Sterilization/disinfection container, reusable

Primary Device ID	00853190008871
NIH Device Record Key	cac4f8c9-a247-47f6-8c07-34f561d19035
Commercial Distribution Status	In Commercial Distribution
Brand Name	Re-entry Base
Version Model Number	315.210.00
Company DUNS	063554875
Company Name	JACE MEDICAL, LLC
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	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853190008871 [Primary]

FDA Product Code

HRS	Plate, Fixation, Bone

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

[00853190008871]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2021-07-08
Device Publish Date	2020-11-06

Devices Manufactured by JACE MEDICAL, LLC

00853190008895 - Universal Plate Cutter	2024-02-23
00850051329014 - Sternalock EZ	2023-11-28 Y Plate, 12 Holes, Narrow
00850051329021 - Sternalock EZ	2023-11-28 Y Plate, 12 Holes, Wide
00853190008352 - Sternalock EZ	2023-11-28 V Plate, 8 Holes
00853190008512 - Sternalock EZ	2023-11-28 V Plate, 4 Holes
00853190008529 - Sternalock EZ	2023-11-28 H Plate, 6 Holes
00853190008635 - Sternalock EZ	2023-11-28 Box Plate, 4 Holes
00853190008642 - Sternalock EZ	2023-11-28 O Plate, 6 Hole

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