FDA.reportPublic FDA data

STILLE Rongeurs

Primary DI
07332339211974
Brand
STILLE Rongeurs
Company
Stille AB
Model
105-13957-18
Catalog number
105-13957-18
Device description
CASPAR STILLE RONGEUR 4x14 mm semi detachable 18 cm 7 in
Published
2020-10-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTXRongeur

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07332339211974PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07332339211974073323392119747332339211974

GMDN Terms#

Term, Definition table
TermDefinition
Spinal rongeurA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (intervertebral disk) or bone, through a cutting/biting action, during open spinal surgery (e.g., laminectomy, discectomy). It is typically made of metal and designed to withstand the forces required to bite over tough tissue. It is not intended for endoscopic access. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length18Centimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+46730333841pontus.luning@stille.se

Regulatory Flags#

DUNS number
355280827
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
07332339220587imagiQSide rail535-17202020-09-24
07332339220617imagiQSide rail535-17242020-09-24
07332339220655imagiQSide rail535-17282020-09-24
07332339220662imagiQFistula arm board535-17302020-09-24
07332339229559imagiQSide rail535-17232020-09-24
07332339232542MedstoneCatheter tray505-11312020-09-24
07332339221614ReisonLeg rest excluding clamp (1 pair)514-1004502022-04-04
07332339220594imagiQSide rail535-17212025-01-27
07332339220624imagiQSide rail535-17252025-01-27
07332339229566imagiQSide rail535-17292025-01-27
07332339242237imagiQPan Handle555-17602024-12-11
07332339242428imagiQPan Handle555-17612024-12-11
07332339242435imagiQCatheter tray 1000mm555-17502024-12-11
07332339242442imagiQCatheter tray 500mm555-17512024-12-11
07332339242459imagiQControl module555-17652024-12-11
07332339242466imagiQControl module555-17662024-12-11
07332339238179imagiQimagiQ3 Legacy550-17002024-11-04
07332339242473imagiQimagiQ3 Legacy550-17022024-11-04
07332339242480imagiQimagiQ3 Legacy550-17032024-11-04
07332339211769STILLE Various Instruments119-30010-15119-30010-152020-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995267902Snowden-PencerSTERIS Deutschland GmbHHTX2026-09-25
00724995274597V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
00724995321390V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
00724995321406V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
00724995321413V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
00724995321420V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
00190776431105MillenniumAvalign Technologies, Inc.HTX2026-09-21
00190776427955MillenniumAvalign Technologies, Inc.HTX2026-08-27
00190776427962MillenniumAvalign Technologies, Inc.HTX2026-08-27
00192896122048Ceramitec Universal Klick Ferris Smith Rongeur ShaftSONTEC INSTRUMENTS, INC.HTX2026-08-25
B382SD9227656000Surgical DirectSurgical Direct, Inc.HTX2026-08-21
00190776426682MillenniumAvalign Technologies, Inc.HTX2026-08-19
00190776426699MillenniumAvalign Technologies, Inc.HTX2026-08-19
B382SD922812030Surgical DirectSurgical Direct, Inc.HTX2026-08-07
00190776422912MillenniumAvalign Technologies, Inc.HTX2026-08-03
00190776422929MillenniumAvalign Technologies, Inc.HTX2026-08-03
B382SD4319D0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD480007LH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD480046220Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD482030LH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD482047PH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD482058LH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD482505LH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD482506LH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD4829130Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD4882030Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD488603SLH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
00190776422455MillenniumAvalign Technologies, Inc.HTX2026-07-31
B382SD1450500050Surgical DirectSurgical Direct, Inc.HTX2026-07-31
B382SD914848050Surgical DirectSurgical Direct, Inc.HTX2026-07-28