FDA.reportPublic FDA data

Bovie

Primary DI
10607151011649
Brand
Bovie
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
AD-770R-A8
Catalog number
AD-770R-A8
Device description
ACUDOP II 770R, DISPLAY RECHARGEABLE UNIT WITH 8MHZ VASCULAR PROBE
Published
2017-03-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
LXEDoppler, Fetal, Ultrasound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
LXEDoppler, Fetal, UltrasoundObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090465000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090465000DIGDOP ULTRASOUND SYSTEMThe Newman Group, LLC2009-04-08ITX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607151011649PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060715101164910607151011649

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
027680821
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887482049938Symmetry Surgical55-868055-86802018-09-25
00887482049945Symmetry Surgical55-868155-86812018-09-25
00887482049952Symmetry Surgical55-868255-86822018-09-25
00887482049969Symmetry Surgical55-868355-86832018-09-25
00887482090282Symmetry Surgical55-868455-86842018-09-25
00887482090299Symmetry Surgical55-868555-86852018-09-25
00840113235445Bovie Fluoro-Dot68022026-10-21
00840113233915RN-Pack66RN2026-10-20
00840113233939High Intensity Medical Penlights Disposable66662026-10-20
00840113235438Diagnostic Medical Penlights63032026-10-20
00840113236367BovieUV592026-10-20
00887482156667Symmetry53-1675RC2026-09-29
10840113232908BovieAA002026-09-21
10840113232922BovieAA00X2026-09-21
10840113232946BovieAA012026-09-21
10840113232960BovieAA01X2026-09-21
10840113232984BovieAA022026-09-21
10840113233004BovieAA032026-09-21
10840113233028BovieAA03X2026-09-21
10840113233042BovieAA042026-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719873001101Esaote MyLabX1 Diagnostic Ultrasound SystemQISDA CORPORATIONITX2026-11-04
04719873001132Esaote MyLabX1 Diagnostic Ultrasound SystemQISDA CORPORATIONITX2026-11-04
04719873001156Esaote MyLabX1 Diagnostic Ultrasound SystemQISDA CORPORATIONITX2026-11-04
06903053063890Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.ITX2026-10-31
06903053063944Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.ITX2026-10-31
06903053064002Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.ITX2026-10-31
08683255231881GTK Disposable Needle GuidesGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIITX2026-10-27
00841517112776Sonosite MTFUJIFILM SONOSITE, INC.ITX2026-10-26
07070554100863Medistim QuickFit TTFM probeMedistim ASAITX2026-10-26
07070554100870Medistim QuickFit TTFM probeMedistim ASAITX2026-10-26
07070554100887Medistim QuickFit TTFM probeMedistim ASAITX2026-10-26
07070554100894Medistim QuickFit TTFM probeMedistim ASAITX2026-10-26
07070554100900Medistim QuickFit TTFM probeMedistim ASAITX2026-10-26
00198953083246VolusonGE Healthcare Austria GmbH & Co OGITX2026-10-09
00198953083253VolusonGE Healthcare Austria GmbH & Co OGITX2026-10-09
00198953083260VolusonGE Healthcare Austria GmbH & Co OGITX2026-10-09
06948941160022Bladder ScannerMeda Co., LtdITX2026-10-08
04719873009510"Esaote MyLabX1" Ultrasound Transducer_Linear ArrayQISDA CORPORATIONITX2026-10-01
04719873009534"Esaote MyLabX1" Ultrasound Transducer_Phased ArrayQISDA CORPORATIONITX2026-10-01
06975424191037Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.ITX2026-10-01
08809887550170EdgeFlow UH10CEdgeCare Inc.ITX2026-09-30
08809887550187EdgeFlow UH10EEdgeCare Inc.ITX2026-09-30
00860007188367FUJIFILMFujifilm Healthcare Americas CorporationITX2026-09-29
00195278985613NAGE Medical Systems (China) Co.,Ltd.ITX2026-09-24
00198953126073VividGE Vingmed Ultrasound A/SITX2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SITX2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SITX2026-09-21
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18