FDA.reportPublic FDA data

AIM

Primary DI
B508EA21007
Brand
AIM
Company
ADVANCED INSTRUMENTATION FOR MEDICINE,INC.
Model
A2-1007
Device description
AIM HOOK SCISSOR 45CM 5MM MONOPOLAR
Published
2017-05-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B508EA21007PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscope system, reusableAn assembly of laparoscopes and their accessories used for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs (laparoscopy). The insertion is typically through an incision(s) made in the abdominal wall (routinely just below the umbilicus or in the near vicinity). This system is mostly used for gynaecological procedures involving the evaluation/treatment of abdominal or pelvic pain, ectopic pregnancy, ovarian cysts, appendicitis, or for female sterilization. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080478537
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B508A11020AIM CLEAR FLUSHA1-10202017-03-13
B508A11363AIM CLEAR FLUSHA1-13632017-03-13
B508A21007AIM CLEAR FLUSHA2-10072017-03-13
B508A21012AIM CLEAR FLUSHA2-10122017-03-13
B508A4316AIM LAPAim4-3162017-10-16
B508A4317AIM LAPA4-3172017-03-13
B508A4318AIM LAPA4-3182017-03-13
B508A4319AIM LAPA4-3192017-03-13
B508A4L317AIM LAPA4-317L2017-03-13
B508A4L318AIM LAPA4-318L2017-03-13
B508A4L319AIM LAPA4-319L2017-03-13
B508A5300AIM LAPA5-3002017-03-13
B508A5315AIM LAPA5-3152017-03-13
B508EA11080Aim Clear FlushA1-10802017-06-12
B508EA11360AIMA1-13602017-06-12
B508EA11363AIM A1-13632017-05-30
B508EA21012AIM CLEAR FLUSHA2-10122017-10-16
B508ESLA11225AIM CLEAR FLUSHA1-1225SL2017-05-02
B508ESLA11226AIM CLEAR FLUSHA1-1226SL2017-05-02
B508ESLA11230AIM CLEAR FLUSHA1-1230SL2017-05-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776427931MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428051MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428303MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776427429MillenniumAvalign Technologies, Inc.GCJ2026-08-26
04580826928451PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928543PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928581PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928604PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
08800035701499CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701505CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701512CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701529CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701536CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701543CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701949CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701956CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701963CORE-TrocarINCORE CO., LTDGCJ2026-08-25
B382SD13448970Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD16008970Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD161730Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205052000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205082000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD7720508TS2000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205252000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
00190776425883MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425906MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425968MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425975MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426361MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426378MillenniumAvalign Technologies, Inc.GCJ2026-08-18