FDA.reportPublic FDA data

RETRA

Primary DI
00857915007040
Brand
RETRA
Company
A.M. SURGICAL, INC.
Model
5500-SR
Device description
RETRA Endoscopic Release System (G2) STERILE For Single Use Only
Published
2026-05-20
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
NBHAccessories, Arthroscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857915007040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857915007040008579150070408579150070400857915007040

GMDN Terms#

Term, Definition table
TermDefinition
Hand ligament surgical release instrumentA hand-held manual surgical instrument designed for use during percutaneous/mini-open surgery to cut a ligament of the hand causing pathological compression. It is typically probe-like in form with a cutting element (e.g., blade, toothed wire) and is typically dedicated to a specific procedure (e.g., carpal tunnel release, trigger finger release). This is a single-use device.

Regulatory Flags#

DUNS number
160020087
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10857915007047RETRA5500-RN/A2026-05-20
00857915007651Elevator9600-062026-05-20
00857915007668Dilator-Small9600-072026-05-20
00857915007675Dilator-Medium9600-082026-05-20
00857915007682Dilator-Large9600-092026-05-20
00857915007699Locking Attachment9600-042026-05-20
00857915007286Secure IM Nail8960-652019-11-14
00857915007293Secure IM Nail8960-702019-11-14
00857915007309Secure IM Nail8912-302019-11-14
00857915007316Secure IM Nail8912-352019-11-14
00857915007323Secure IM Nail8912-402019-11-14
00857915007330Secure IM Nail8912-452019-11-14
00857915007347Secure IM Nail8912-502019-11-14
00857915007354Secure IM Nail8912-552019-11-14
00857915007361Secure IM Nail8912-602019-11-14
00857915007378Secure IM Nail8912-652019-11-14
00857915007385Secure IM Nail8912-702019-11-14
00857915007057Secure IM Nail8960-402018-07-16
00857915007064Secure IM Nail8960-452018-07-16
00857915007071Secure IM Nail8960-502018-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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