FDA.reportPublic FDA data

Inspire

Primary DI
10810098650066
Brand
Inspire
Company
Inspire Medical Systems, Inc.
Model
900-023-001
Catalog number
5030
Device description
A nonpowered neurosurgical instrument is a hand instrument or an accessory to a hand instrument used during neurosurgical procedures to cut, hold, or manipulate tissue. It includes specialized chisels, osteotomes, curettes, dissectors, elevators, forceps, gouges, hooks, surgical knives, rasps, scissors, separators, spatulas, spoons, blades, blade holders, blade breakers, probes, etc.
Published
2025-10-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HAOInstrument, Surgical, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAOInstrument, Surgical, Non-PoweredNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810098650066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081009865006610810098650066

GMDN Terms#

Term, Definition table
TermDefinition
Subcutaneous tunneller, single-useA hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt). It is available in a variety of forms and may be: 1) a luminal sheath with a removable inner obturator, intended for co-axial device introduction, followed by sheath removal; or 2) a non-luminal device intended to either lead or pull the device through subcutaneous tissue. It is not intended for tunnelling through deep tissues and is not a dedicated pacing or defibrillation lead tunneller. This is a single-use device.

Regulatory Flags#

DUNS number
012419779
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10855728005793Inspire900-013-00140632025-07-29
10810098650295Inspire900-013-00340632025-02-24
00855728005796Inspire900-013-00140632022-08-16
10810098650301Inspire900-014-00543402025-02-24
00810098650311Inspire900-026-0012740S&C2025-01-21
10855728005960Inspire900-015-00131502024-12-06
00810098650175Inspire900-017-00525802024-10-10
00810098650199Inspire900-017-05325802024-10-10
00855728005994Inspire900-018-0012740C2024-09-11
10810098650264Inspire900-007-01930282024-07-08
00810098650038Inspire900-029-0012740S2024-05-15
00810098650212Inspire900-004-11727402024-01-03
00810098650151Inspire900-004-11627402023-04-26
10810098650141Inspire900-007-01730282023-04-06
00810098650014Inspire900-017-005125802023-01-13
00810098650083Inspire900-017-00325802022-09-29
00855728005949Inspire900-014-00343402022-08-16
00855728005925Inspire900-017-00125802022-05-09
00810098650007Inspire900-004-11527402022-01-26
00855728005741Inspire900-004-11127402021-03-19

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Primary DI, Brand, Company table
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04946329056457CEA Scissors 180 mm, Sideward Cvd.MIZUHO CORPORATIONHAO2026-05-29
04946329056464CEA Micro Scissors 170 mm, 35 deg. Downward Cvd.MIZUHO CORPORATIONHAO2026-05-29
04946329056471CEA Thin Needle Holder 170 mmMIZUHO CORPORATIONHAO2026-05-29
04946329056488CEA Micro Forceps 180 mm, Cvd.MIZUHO CORPORATIONHAO2026-05-29
04946329056495CEA Micro Forceps 180 mm, L Str.MIZUHO CORPORATIONHAO2026-05-29
04946329056501CEA Micro Forceps 150 mm, S Str.MIZUHO CORPORATIONHAO2026-05-29
04946329058802Yasargil micro raspatory, curved, 18.5 cmMIZUHO CORPORATIONHAO2026-05-29
04946329058987Micro Scissors 130 mm, FHMIZUHO CORPORATIONHAO2026-05-29
04946329077476Pediatric Mosquito Applier without Hook StrMIZUHO CORPORATIONHAO2026-05-29
04946329077582Bulldog Clamp 82 mm, L Str.MIZUHO CORPORATIONHAO2026-05-29
04946329077599Bulldog Clamp 67 mm, S Str.MIZUHO CORPORATIONHAO2026-05-29
04946329077605Bulldog Clamp 54 mm, L-Shaped.MIZUHO CORPORATIONHAO2026-05-29
04946329077612Bulldog Clamp 67 mm, L Cvd.MIZUHO CORPORATIONHAO2026-05-29
04946329077629Bulldog Clamp 57 mm, S Cvd.MIZUHO CORPORATIONHAO2026-05-29
04946329150216Micro Scissors Streamline S, 175 mm Straight, Super Fine TipMIZUHO CORPORATIONHAO2026-05-29
04946329150223Micro Scissors Streamline S, 175 mm Curved, Super Fine TipMIZUHO CORPORATIONHAO2026-05-29
04946329150230Micro Scissors Streamline M, 190 mm Straight, Super Fine TipMIZUHO CORPORATIONHAO2026-05-29
04946329150247Micro Scissors Streamline M, 190 mm Curved, Super Fine TipMIZUHO CORPORATIONHAO2026-05-29
04946329150254Micro Scissors Streamline L, 220 mm Straight, Super Fine TipMIZUHO CORPORATIONHAO2026-05-29
04946329150261Micro Scissors Streamline L, 220 mm Curved, Super Fine TipMIZUHO CORPORATIONHAO2026-05-29
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