FDA.reportPublic FDA data

PIT'STOP®

Primary DI
03701337607005
Brand
PIT'STOP®
Company
IN2BONES
Model
M02 10031
Published
2022-05-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701337607005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701337607005037013376070053701337607005

GMDN Terms#

Term, Definition table
TermDefinition
Instrument transport trolley systemA combination of carts and/or portable containers designed for safe storage, handling, and transportation of reusable clinical instruments (typically endoscopes or surgical instruments) between the operating and central sterilization rooms. It typically consists of an instrument trolley (cart) with containers; smaller systems may consist of portable closed trays or boxes with gasket seals and/or filters.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+33472292626contact@in2bones.com
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
263616749
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701337618896QUANTUM®M05 10211M05 102112025-12-09
03701337618919QUANTUM®M05 10212M05 102122025-12-09
03701337621995QUANTUM®M05 10213M05 102132025-12-09
03701337612085QUANTUMM05 00192M05 001922024-12-27
03701337600532QUANTUMM05 00541M05 005412024-12-13
03701337600549QUANTUMM05 00551M05 005512024-12-13
03701337600556QUANTUMM05 00561M05 005612024-12-13
03701337600563QUANTUMM05 00571M05 005712024-12-13
03701337600570QUANTUMM05 00581M05 005812024-12-13
03701337600587QUANTUMM05 00591M05 005912024-12-13
03701337600594QUANTUMM05 00601M05 006012024-12-13
03701337600600QUANTUMM05 00611M05 006112024-12-13
03701337600617QUANTUMM05 00621M05 006212024-12-13
03701337600624QUANTUMM05 00631M05 006312024-12-13
03701337600631QUANTUMM05 00641M05 006412024-12-13
03701337600648QUANTUMM05 00651M05 006512024-12-13
03701337600679QUANTUMM05 00681M05 006812024-12-13
03701337600686QUANTUMM05 00691M05 006912024-12-13
03701337600815QUANTUMM05 00811M05 008112024-12-13
03701337600822QUANTUMM05 01161M05 011612024-12-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850075235063TESA IF Screw SystemTesa Medical, Inc.FSM2026-05-26
00850075235070TESA Tensioner SystemTesa Medical, Inc.FSM2026-05-26
00850075235179TESA Tensioner SystemTesa Medical, Inc.FSM2026-05-26
10889950157326Hu-FriedyHU-FRIEDY MFG. CO., LLCFSM2026-05-26
00888118150240PURE PECTUSKLS-Martin L.P.FSM2026-05-25
00888118150257PURE PECTUSKLS-Martin L.P.FSM2026-05-25
00888118150264PURE PECTUSKLS-Martin L.P.FSM2026-05-25
00888118150448IXOSKLS-Martin L.P.FSM2026-05-25
00888118150455IXOSKLS-Martin L.P.FSM2026-05-25
00888118150462IXOSKLS-Martin L.P.FSM2026-05-25
00888118150479IXOSKLS-Martin L.P.FSM2026-05-25
00888118150486IXOSKLS-Martin L.P.FSM2026-05-25
00888118150493IXOSKLS-Martin L.P.FSM2026-05-25
00888118153029L1 STERNALKLS-Martin L.P.FSM2026-05-25
00888118153050IXOSKLS-Martin L.P.FSM2026-05-25
00888118153067IXOSKLS-Martin L.P.FSM2026-05-25
00888118153074IXOSKLS-Martin L.P.FSM2026-05-25
00888118153081IXOSKLS-Martin L.P.FSM2026-05-25
00888118154613LEVEL ONEKLS-Martin L.P.FSM2026-05-25
07898663491562HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663493108HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663493467HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663495263HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663495270HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663495751HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663496239HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663497267HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663498080HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663498097HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663499292HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24