FDA.reportPublic FDA data

StabilICE

Primary DI
00850027837529
Brand
StabilICE
Company
ACUTUS MEDICAL, INC.
Model
900218
Catalog number
900218
Device description
StabilICE
Published
2021-10-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWSInstruments, Surgical, Cardiovascular
HYAForceps, Wire Holding

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1
HYAForceps, Wire HoldingGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850027837529PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850027837529008500278375298500278375290850027837529

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(442)232-6100product.complaints@acutus.com

Regulatory Flags#

DUNS number
844418199
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
00850027837666AcQGuide MAX900200-003900200-0032023-08-30
00857042007906AcQGuide VUE9002019002012022-05-13
00850027837017AcQGuide MAX9002009002002021-10-08
00857042007432AcQGuide1128522019-07-24
00857042007456AcQGuide1228521228522019-07-24
00857042007012AcQGuide9000029000022018-02-15
00850027837253DiamondTemp Generator Adapter8007278007272022-10-24
00850027837635DiamondTemp Generator Adapter8008188008182022-10-24
00850027837642StabilICE9002219002212022-04-01
00850027837659StabilICE9002189002182022-04-01
00850027837192AcQMap8006988006982022-02-01
00850027837222AcQMap8006958006952022-02-01
00850027837239AcQMap8006968006962022-02-01
00850027837246AcQMap8006978006972022-02-01
00850027837444AcQMap8007108007102022-02-01
00850027837451AcQMap8007398007392022-02-01
00850027837468AcQMap8007428007422022-02-01
00850027837475AcQMap8007458007452022-02-01
00850027837482AcQMap8007488007482022-02-01
00857042007333AcQMap8006018006012022-02-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03661219008224LANDANGERLANDANGERDWS2026-10-12
03661219389811DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219510024DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525486DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525509DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525523DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525547DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525561DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525585DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525608DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525943DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525950DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525967DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525974DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525981DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219527442DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
04058749009897NAFehling Instruments GmbH & Co. KGDWS2026-10-12
04058749125931NAFehling Instruments GmbH & Co. KGDWS2026-10-12
03661219320265DELACROIX-CHEVALIERLANDANGERDWS2026-10-11
03661219438601DELACROIX-CHEVALIERLANDANGERDWS2026-10-11
03661219442943DELACROIX-CHEVALIERLANDANGERDWS2026-10-11
03661219528388DELACROIX-CHEVALIERLANDANGERDWS2026-10-11
00190776434236MillenniumAvalign Technologies, Inc.DWS2026-10-09
00190776436216MillenniumAvalign Technologies, Inc.DWS2026-10-08
00190776436254MillenniumAvalign Technologies, Inc.DWS2026-10-08
00190776436315MillenniumAvalign Technologies, Inc.DWS2026-10-08
00190776436353MillenniumAvalign Technologies, Inc.DWS2026-10-08
00190776436377MillenniumAvalign Technologies, Inc.DWS2026-10-08
00190776436438MillenniumAvalign Technologies, Inc.DWS2026-10-08
00190776434410MillenniumAvalign Technologies, Inc.DWS2026-10-07