FDA.reportPublic FDA data

Bovie

Primary DI
00840113242764
Brand
Bovie
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
SETWS
Device description
Vacuum Hose 7/8" X 6' w/Wand Sponge Guard
Published
2026-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAZTubing, Noninvasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAZTubing, NoninvasiveGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840113242764PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840113242764008401132427648401132427640840113242764

GMDN Terms#

Term, Definition table
TermDefinition
Surgical plume evacuation system tubeA long, hollow cylinder which, as part of a surgical plume evacuation system, is intended to be used to capture, conduct, and exhaust the plume of smoke generated during open surgical procedures in which there is tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
8883647004customerservice@aspensurgical.com

Regulatory Flags#

DUNS number
027680821
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
00840113233281BovieH1002026-09-04
00840113233304BovieH1012026-09-04
00840113233328BovieH101-ADH2026-09-04
00840113233342BovieH1032026-09-04
00840113233366BovieH1042026-09-04
00840113233380BovieH1052026-09-04
00840113233403BovieH1062026-09-04
00840113233427BovieH1092026-09-04
00840113233441BovieH1102026-09-04
00840113233465BovieH1112026-09-04
00840113233489BovieH1122026-09-04
00840113233502BovieH1212026-09-04
00840113233526BovieHISL2026-09-04
00840113237326BovieESP1N2026-09-04
00840113237340BovieESP1H2026-09-04
00840113237593BovieESP7N2026-09-04
00840113237623BovieESP7H2026-09-04
00840113237661BovieESP6N2026-09-04
00840113237692BovieESP6H2026-09-04
00840113242573BovieST052026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840113242771BovieASPEN SURGICAL PRODUCTS, INC.GAZ2026-09-04
00840113242818BovieASPEN SURGICAL PRODUCTS, INC.GAZ2026-09-04
00810194403514AiraAIRA, LLCGAZ2026-08-26
00840329834494BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GAZ2026-07-30
00840329836856BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GAZ2026-07-30
10080196992805MEDLINEMEDLINE INDUSTRIES, INC.GAZ2026-06-22
10080196144310MEDLINEMEDLINE INDUSTRIES, INC.GAZ2026-06-08
10884389123997MEDLINEMEDLINE INDUSTRIES, INC.GAZ2026-06-08
10885380072352CARDINAL HEALTHCardinal Health 200, LLCGAZ2026-02-13
10080196035106MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196035120MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196035151MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196035168MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196035229MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196035243MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196035250MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196996063MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10192253042917ArgyleCardinal Health 200, LLCGAZ2025-02-27
10192253043051ArgyleCardinal Health 200, LLCGAZ2025-02-27
08809083944803EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944810EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944827EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944834EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944841EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944858EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944865EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944872EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944889EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944896EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944902EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28