FDA.reportPublic FDA data

Accessories, arthroscopic

Primary DI
00816342021074
Brand
Accessories, arthroscopic
Company
PARCUS MEDICAL LLC
Model
10300
Device description
Guide Wire,2.7x38 W/EYE TROCAR
Published
2023-07-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NBHAccessories, Arthroscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816342021074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816342021074008163420210748163420210740816342021074

GMDN Terms#

Term, Definition table
TermDefinition
Cannulated surgical drill guiding pinA sterile metal shaft (pin) designed to fit into the hollow centre of a cannulated surgical drill bit to provide a guide for drilling during a surgical procedure. The pin is bored into hard tissue (e.g., bone), typically by means of a surgical power tool handpiece, and the cannulated drill bit is subsequently fed over it during the drilling procedure. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
859961950
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816342022033Graft Fixation System200422025-09-16
00816342022040Graft Fixation System200492025-09-16
00816342022057Graft Fixation System200532025-09-16
00816342022064Graft Fixation System200542025-09-16
00816342022071Graft Fixation System200552025-09-16
00816342022088Graft Fixation System200562025-09-16
00816342022095Graft Fixation System200592025-09-16
00816342022101Graft Fixation System200602025-09-16
00816342023887Graft Fixation System200462025-09-16
00816342023900Graft Fixation System200502025-09-16
00816342023955Graft Fixation System20042S2025-09-16
00816342024204Graft Fixation System20049S2025-09-16
00816342024211Graft Fixation System20035S2025-09-16
00816342024228Graft Fixation System20055S2025-09-16
00816342024235Graft Fixation System20054S2025-09-16
00816342024242Graft Fixation System20059S2025-09-16
00816342024259Graft Fixation System20053S2025-09-16
00816342024266Graft Fixation System20056S2025-09-16
00816342024273Graft Fixation System20032S2025-09-16
00816342024280Graft Fixation System20034S2025-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00857915007705STRATOS (Gen2)A.M. SURGICAL, INC.NBH2026-06-05
00857915007033RetraBE Single - Gen 2 DepricatedA.M. SURGICAL, INC.NBH2026-06-04
00857915007781Retra Uni Gen 1 (5-Pack)A.M. SURGICAL, INC.NBH2026-06-04
00857915007798Retra Uni Gen 1 SingleA.M. SURGICAL, INC.NBH2026-06-04
10857915007030RETRA Single - GEN 2 DepricatedA.M. SURGICAL, INC.NBH2026-06-04
00857915007026Scope AdapterA.M. SURGICAL, INC.NBH2026-06-01
04059453163318Hermann Medizintechnik GmbHHermann Medizintechnik GmbHNBH2026-05-29
00857915007699Locking AttachmentA.M. SURGICAL, INC.NBH2026-05-20
07630345721204Surgical Manual InstrumentMedacta International SANBH2026-03-30
07630345721211Surgical Manual InstrumentMedacta International SANBH2026-03-30
07630345721228Surgical Manual InstrumentMedacta International SANBH2026-03-30
10080196385386MEDLINEMEDLINE INDUSTRIES, INC.NBH2025-02-21
10080196385478MEDLINEMEDLINE INDUSTRIES, INC.NBH2025-02-21
10080196392032MEDLINEMEDLINE INDUSTRIES, INC.NBH2025-02-21
10080196392070MEDLINEMEDLINE INDUSTRIES, INC.NBH2025-02-21
10080196392292MEDLINEMEDLINE INDUSTRIES, INC.NBH2025-02-21
10080196385218MEDLINEMEDLINE INDUSTRIES, INC.NBH2025-01-29
10845854026946DOUBLELATCHConmed CorporationNBH2023-12-05
10080196387984MedlineMEDLINE INDUSTRIES, INC.NBH2023-10-09
07630345778765Sports Med InstrumentsMedacta International SANBH2023-01-16
07630542702457Sports Med InstrumentsMedacta International SANBH2023-01-16
07613327379624NASTRYKER CORPORATIONNBH2022-12-06
10845854030387Hip Preservation System, PopLokConmed CorporationNBH2022-06-11
10845854028711CONMEDConmed CorporationNBH2021-10-14
10845854029893HIP PRESERVATION SYSTEM SIGNATURE SERIESConmed CorporationNBH2021-10-14
10845854017418Dry-DocConmed CorporationNBH2021-10-12
10845854017845Dry-DocConmed CorporationNBH2021-10-12
10845854018118CONMEDConmed CorporationNBH2021-10-12
10845854018408HEX FLEXConmed CorporationNBH2021-10-12
10845854018415HEX FLEXConmed CorporationNBH2021-10-12