FDA.reportPublic FDA data

Spring Op Hand

Primary DI
05056349560625
Brand
Spring Op Hand
Company
HUGH STEEPER LIMITED
Model
Spring Operated Hand 7 1/4 Right - 1/2 X 20 Tpi
Catalog number
SPA725RNA
Published
2023-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IRAHand, External Limb Component, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRAHand, External Limb Component, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056349560625PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056349560625050563495606255056349560625

GMDN Terms#

Term, Definition table
TermDefinition
Body-powered hand prosthesisAn artificial substitute for a missing hand that may be attached to a natural arm or used as part of an upper-limb external prosthetic system, and is designed to replace the appearance and some of the function of the hand. The device moves as the result of connecting straps/cables or other mechanism powered by the movement of body segments.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
210280350
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05063368529106BATTERY SYSTEMLITHIUM BATTERY CHARGERLIBCH2023-10-04
05063368529502BATTERY SYSTEM50MM KINISI SH WR HOUSINGMKSW502023-10-04
05063368529496BATTERY SYSTEM45MM KINISI SH WR HOUSINGMKSW452023-10-04
05063368529519BATTERY SYSTEM50MM KINISI SH WR HOUSING M12BBSW50-M122023-10-04
05063368529526Wrist45MM STEEPER FR HD PL KITSFW0452023-10-04
50633685291064BATTERY SYSTEMLITHIUM BATTERY CHARGERLIBCH2023-10-04
50633685295024BATTERY SYSTEM50MM KINISI SH WR HOUSINGMKSW502023-10-04
05055348200228S-CHARGES-Charger - Wall Charger KitSWC22002023-08-08
05055348248602PVC GloveTrueFinish ™ PVC Glove Childs Number# Colour# TG20/E22023-08-08
05055348249784PVC GloveTrueFinish ™ PVC Glove Male HD Number# Colour# TG104/E62023-08-08
05055348252708PVC GloveTrueFinish ™ PVC Glove Female Adult HD Number# ColTG106L/E82023-08-08
05056349561615PVC GloveTrueFinish ™ PVC Glove Female Adult HD Number# ColTG106L/E32023-08-08
05056349561622PVC GloveTrueFinish ™ PVC Glove Female Adult HD Number# ColTG106L/E52023-08-08
05056349561639PVC GloveTrueFinish ™ PVC Glove Female Adult HD Number# ColTG106L/E72023-08-08
05056349561646PVC GloveTrueFinish ™ PVC Glove Female Adult HD Number# ColTG106L/E92023-08-08
05056349563251PVC GloveTrueFinish ™ PVC Glove Childs Number# Colour# TG19/E32023-08-08
05056349563428PVC GloveTrueFinish ™ PVC Glove Male Number# Colour# TG2/E32023-08-08
05056349563473PVC GloveTrueFinish ™ PVC Glove Childs Number# Colour# TG20/E12023-08-08
05056349563725PVC GloveTrueFinish ™ PVC Glove Male Number# Colour# TG200/E22023-08-08
05056349563923PVC GloveTrueFinish ™ PVC Glove Male Number# Colour# TG201/E32023-08-08

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Primary DI, Brand, Company table
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04719883463524TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IRA2025-01-10
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