FDA.reportPublic FDA data

ACL

Primary DI
00841132124277
Brand
ACL
Company
ORTHOPEDIATRICS CORP.
Model
01-1008-2530
Catalog number
01-1008-2530
Device description
2.5MM X 300MM GUIDE WIRE, SMOOTH, COCR
Published
2021-07-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZHApparatus, air handling, room

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZHApparatus, Air Handling, RoomGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841132124277PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841132124277008411321242778411321242770841132124277

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(574)268-6379bsmith@orthopediatrics.com

Regulatory Flags#

DUNS number
796416191
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008405368000393P Hip System01-3002-101301-3002-10132026-06-09
008405368000463P Hip System01-3002-201301-3002-20132026-06-09
008405368000533P Hip System01-3002-301301-3002-30132026-06-09
008405368000603P Hip System01-3035-005001-3035-00502026-06-09
00840536822741Response 5.5/6.001-1300-653501-1300-65352026-05-30
00840536822758Response 5.5/6.001-1300-653601-1300-65362026-05-30
00840536822543Prone Perfect03-1300-880103-1300-88012026-05-22
00840536822550Prone Perfect03-1300-880203-1300-88022026-05-22
00840536822567Prone Perfect03-1300-880303-1300-88032026-05-22
00840536822574Prone Perfect03-1300-880403-1300-88042026-05-22
00840536822581Prone Perfect03-1300-880503-1300-88052026-05-22
00840536822598Prone Perfect03-1300-880603-1300-88062026-05-22
00840536822604Prone Perfect03-1300-880703-1300-88072026-05-22
00840536822611Prone Perfect03-1300-880803-1300-88082026-05-22
00840536822628Prone Perfect03-1300-880903-1300-88092026-05-22
00840536822635Prone Perfect03-1300-881003-1300-88102026-05-22
00840536822642Prone Perfect03-1300-881103-1300-88112026-05-22
00841132199244OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6000-S00-1200-6000-S2026-05-13
00841132199251OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6001-S00-1200-6001-S2026-05-13
00841132199268OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6002-S00-1200-6002-S2026-05-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00852348007155AerobiotixAEROBIOTIX, INC.FZH2023-06-30
00852348007179AerobiotixAEROBIOTIX, INC.FZH2023-06-30
00852348007186AerobiotixAEROBIOTIX, INC.FZH2023-06-30
00852348007193AerobiotixAEROBIOTIX, INC.FZH2023-06-30
00852348007308IlluviaAEROBIOTIX, INC.FZH2023-06-02
00852348007988IlluviaAEROBIOTIX, INC.FZH2023-03-01
00852348007322IlluviaAEROBIOTIX, INC.FZH2021-12-03
00852348007896IlluviaAEROBIOTIX, INC.FZH2021-12-03
00852348007292IlluviaAEROBIOTIX, INC.FZH2021-09-01
00852348007889IlluviaAEROBIOTIX, INC.FZH2021-09-01
06973495370061JUD careShenzhen Juding Medical Co., Ltd.FZH2021-06-25
06973495370078JUD careShenzhen Juding Medical Co., Ltd.FZH2021-06-25
06973495370085JUD careShenzhen Juding Medical Co., Ltd.FZH2021-06-25
16973495370006JUD careShenzhen Juding Medical Co., Ltd.FZH2021-06-25
06973495370023JUD careShenzhen Juding Medical Co., Ltd.FZH2021-03-08
06973495370030JUD careShenzhen Juding Medical Co., Ltd.FZH2021-03-08
06973495370047JUD careShenzhen Juding Medical Co., Ltd.FZH2021-03-08
26973495370003JUD careShenzhen Juding Medical Co., Ltd.FZH2021-03-08
00852348007117IlluviaAEROBIOTIX, INC.FZH2019-02-14
00852348007223IlluviaAEROBIOTIX, INC.FZH2019-02-14
00852348007995IlluviaAEROBIOTIX, INC.FZH2019-02-14