GUDID 00850005084952

12 Inch Scalpel

PACIFIC INSTRUMENTS, INC.

Scalpel handle, reusable
Primary Device ID00850005084952
NIH Device Record Key6613bcad-e68a-42c5-9c05-6e48c17478fb
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberPI-1760
Company DUNS621872006
Company NamePACIFIC INSTRUMENTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850005084952 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850005084952]

Moist Heat or Steam Sterilization


[00850005084952]

Moist Heat or Steam Sterilization


[00850005084952]

Moist Heat or Steam Sterilization


[00850005084952]

Moist Heat or Steam Sterilization


[00850005084952]

Moist Heat or Steam Sterilization


[00850005084952]

Moist Heat or Steam Sterilization


[00850005084952]

Moist Heat or Steam Sterilization


[00850005084952]

Moist Heat or Steam Sterilization


[00850005084952]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-25
Device Publish Date2025-04-17

Devices Manufactured by PACIFIC INSTRUMENTS, INC.

00810168190112 - NA2025-05-30 Distraction Screw, 14mm
00850005084952 - NA2025-04-2512 Inch Scalpel
00850005084952 - NA2025-04-25 12 Inch Scalpel
00850005084969 - NA2025-04-25 6.0 Double Action Rod Gripper
00850005084983 - NA2025-04-18 Bone Holding Forceps
00850005084990 - NA2025-04-18 Bone Reduction Forceps, Curved, Pointed Tips, 131mm OAL
00850005084938 - NA2024-12-26 Sure Grip 120, OAL 197mm, AO QC, Ratcheting, Cannulated
00850005084921 - NA2024-11-14 TBD
00850005084723 - NA2024-10-08 Ø4.0mm Carbide Drill Bit 75 mm OAL, Left Hand

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