FDA.reportPublic FDA data

NA

Primary DI
00849771052166
Brand
NA
Company
KEY SURGICAL, INC.
Model
Instrument Stringers
Catalog number
IS12512
Device description
Instrument Stringers, stainless steel, 12-inch x 2.5-inch
Published
2024-02-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849771038450PreviousGS10
00849771052166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849771038450008497710384508497710384500849771038450
00849771052166008497710521668497710521660849771052166

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width0

Sterilization Methods#

Method table
Method
Ethylene Oxide
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
604056226
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
true
Expiration date on label
false
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
10849771039997Key Surgical Sterile LabelsSL118SL1182022-11-02
10849771043178Sterile LabelsSL212SL2122023-04-18
10849771050718Sterile LabelsSL202SL2022023-04-24
10849771052767Sterile LabelsSL101SL1012024-03-22
10849771052774Sterile LabelsSL103SL1032024-03-22
10849771052781Sterile LabelsSL104SL1042024-03-22
10849771052798Sterile LabelsSL107SL1072024-03-22
10849771052804Sterile LabelsSL110SL1102024-03-22
10849771052842Sterile LabelsSL201SL2012024-03-22
10849771052866Sterile LabelsSL208SL2082024-03-22
10849771052910Sterile LabelsSL213SL2132023-04-18
10849771052927Sterile LabelsSL214SL2142023-04-18
00849771040071NAInstrument StringerIS425142023-01-26
00849771040088NAInstrument StringerIS425162023-01-26
00849771052203NAInstrument StringerIS5350082023-01-26
00849771052210NAInstrument StringerIS555142023-01-26
00849771031307Key Surgical Indicator Dot Locking TagsLS-105LS-1052020-01-29
00849771032588Key Surgical Indicator Dot Locking TagsLS-104LS-1042020-01-29
00849771048596NAPlastic Sterilization TrayPST2100SB2023-01-26
00849771048602NAPlastic Sterilization TrayPST3100SB2023-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810240701274G Surgical Marksman SystemG SURGICAL LLCMDM2026-11-05
00810240701281G Surgical Marksman SystemG SURGICAL LLCMDM2026-11-05
00190776437404MillenniumAvalign Technologies, Inc.MDM2026-11-02
00190776437411MillenniumAvalign Technologies, Inc.MDM2026-11-02
B35671626000American MedicalsAmerican MedicalsMDM2026-11-02
B3567162600250American MedicalsAmerican MedicalsMDM2026-11-02
00190776437237MillenniumAvalign Technologies, Inc.MDM2026-10-30
00877234001918Chord-X® Chordal SizerArtivion, Inc.MDM2026-10-30
00888867620940Arthrex®ARTHREX, INC.MDM2026-10-29
00190776436834MillenniumAvalign Technologies, Inc.MDM2026-10-22
07540277009663RMAC Surgical MarkerRMAC Surgical, IncMDM2026-10-21
00190776435080MillenniumAvalign Technologies, Inc.MDM2026-10-15
00840456225332JMUJMU DENTAL, INCMDM2026-10-13
00840456225349JMUJMU DENTAL, INCMDM2026-10-13
06955045515634hoboatJiangsu Hope Biomedical Science&Technology Co.,Ltd.MDM2026-10-13
06955045515689hoboatJiangsu Hope Biomedical Science&Technology Co.,Ltd.MDM2026-10-13
00190776434120MillenniumAvalign Technologies, Inc.MDM2026-10-09
00190776434229MillenniumAvalign Technologies, Inc.MDM2026-10-09
00190776433840MillenniumAvalign Technologies, Inc.MDM2026-10-08
00190776433857MillenniumAvalign Technologies, Inc.MDM2026-10-08
00190776433673MillenniumAvalign Technologies, Inc.MDM2026-10-07
00190776436162MillenniumAvalign Technologies, Inc.MDM2026-10-07
G141526051160Carnegie Surgical LLCCarnegie Surgical LLCMDM2026-10-07
00190776433536MillenniumAvalign Technologies, Inc.MDM2026-10-06
00190776434311MillenniumAvalign Technologies, Inc.MDM2026-10-06
00810220800584Adler Instrument CompanyAdler, Inc.MDM2026-09-30
00190776432775MillenniumAvalign Technologies, Inc.MDM2026-09-29
00888867618961Arthrex®ARTHREX, INC.MDM2026-09-28
00888867621237Arthrex®ARTHREX, INC.MDM2026-09-28
10888277689251MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28