FDA.reportPublic FDA data

MACI Arthroscopic Instruments

Primary DI
00850037506248
Brand
MACI Arthroscopic Instruments
Company
VERICEL CORPORATION
Model
82036
Catalog number
N/A
Device description
14 mm x 26 mm Min Arthroscopic Cutter and 14 mm x 26 mm MACI Cutter Kit
Published
2024-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FZTCutter, Surgical
NBHAccessories, Arthroscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZTCutter, SurgicalGeneral, Plastic Surgery1
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850037506248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850037506248008500375062488500375062480850037506248

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical and endoscopic instruments, dressings, and additional materials intended to be used specifically to perform an arthroscopic surgical procedure. It does not contain any pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079745570
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850037506132MACI Surgical Implantation KitN/A2022-11-09
00850037506101Cutting Block890542022-11-09
00850037506057MACI Arthroscopic Instruments82024N/A2024-09-18
00850037506224MACI Arthroscopic Instruments82034N/A2024-09-18
00850037506262MACI Arthroscopic Instruments82038N/A2024-09-18
00850037506002MACI Arthroscopic Instruments82032N/A2024-08-26
00850037506019MACI Arthroscopic Instruments82023N/A2024-08-26
00850037506026MACI Arthroscopic Instruments82021N/A2024-08-26
00850037506033MACI Arthroscopic Instruments82020N/A2024-08-26
00850037506040MACI Arthroscopic Instruments82022N/A2024-08-26
00850037506064MACI Arthroscopic Instruments82026N/A2024-08-26
00850037506088MACI Arthroscopic Instruments82016N/A2024-08-26
00850037506217MACI Arthroscopic Instruments82033N/A2024-08-26
00850037506231MACI Arthroscopic Instruments82035N/A2024-08-26
00850037506255MACI Arthroscopic Instruments82037N/A2024-08-26
00850037506279MACI Arthroscopic Instruments89060N/A2024-08-26
00860004093022MACI Arthroscopic Instruments82017N/A2024-08-26
00860004093039MACI Arthroscopic Instruments82018N/A2024-08-26
00860004093046MACI Arthroscopic Instruments82025N/A2024-08-26
00860004093053MACI Arthroscopic Instruments82027N/A2024-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD319590Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD480084LH0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD48008SLH0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481014SLH0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481022LH0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481752CBDYN0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481752PT0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481755STR0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481756STR0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481760DYN0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD483003STR0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD487193000Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD487223000Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD5235320Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD142090Surgical DirectSurgical Direct, Inc.NBH2026-07-31
B382SD1814DK70Surgical DirectSurgical Direct, Inc.NBH2026-07-31
B382SD18252590Surgical DirectSurgical Direct, Inc.NBH2026-07-31
B382SD30609CH0Surgical DirectSurgical Direct, Inc.NBH2026-07-31
B382SD316390Surgical DirectSurgical Direct, Inc.NBH2026-07-31
00198506093258ELMED INCORPORATEDELMED INCORPORATEDNBH2026-07-28
00810143908534SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909449SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909456SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909463SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909470SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909487SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909494SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909500SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909531SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909555SURGIPROSSurgipros, LLCNBH2026-07-28