FDA.reportPublic FDA data

Response Spine System

Primary DI
00840194462709
Brand
Response Spine System
Company
ORTHOPEDIATRICS CORP.
Model
01-1300-8262
Catalog number
01-1300-8262
Device description
Stylet - Luer Lock Cannulated Tap
Published
2024-02-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GAHSTYLET, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAHStylet, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840194462709PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840194462709008401944627098401944627090840194462709

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide obturatorA surgical device designed to fill the lumen of a drill guide during its insertion to a surgical site primarily to prevent tissue obstruction of the drill guide lumen. When the drill guide is firmly placed at the chosen position on the bone surface, the obturator is removed. It is typically a rod with a rounded distal end, which protrudes out of the drill guide, and a knob-like handle that functions as a regulator to control the length of the protruding end and to remove it from the drill guide. It is typically made of a high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00841132199275OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6003-S00-1200-6003-S2026-05-13
00841132199282OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6004-S00-1200-6004-S2026-05-13
00841132199299OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6005-S00-1200-6005-S2026-05-13
00841132199305OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6006-S00-1200-6006-S2026-05-13
00841132199312OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6014-S00-1200-6014-S2026-05-13
00841132199329OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6015-S00-1200-6015-S2026-05-13

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