FDA.reportPublic FDA data

PlastiBell Circumcision Device

Primary DI
00840113231676
Brand
PlastiBell Circumcision Device
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
9237
Device description
1.7 cm PlastiBell Circumcision Device
Published
2023-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FHGBell, circumcision

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHGBell, CircumcisionObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840113231676PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840113231676008401132316768401132316760840113231676

GMDN Terms#

Term, Definition table
TermDefinition
Surgical penis clamp, single-useA sterile, hand-held manual surgical instrument designed to grasp the penis for manipulation during surgery (e.g., circumcision). It is typically a clip-like device e.g., with self-retaining levers. The penis is placed into this clamp that closes around or on the organ. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
027680821
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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
00840113231539PlastiBell Circumcision DeviceASPEN SURGICAL PRODUCTS, INC.FHG2023-02-27
00840113231546PlastiBell Circumcision DeviceASPEN SURGICAL PRODUCTS, INC.FHG2023-02-27
00840113231560PlastiBell Circumcision DeviceASPEN SURGICAL PRODUCTS, INC.FHG2023-02-27
00840113231577PlastiBell Circumcision DeviceASPEN SURGICAL PRODUCTS, INC.FHG2023-02-27
00840113231584PlastiBell Circumcision DeviceASPEN SURGICAL PRODUCTS, INC.FHG2023-02-27
00840113231591PlastiBell Circumcision DeviceASPEN SURGICAL PRODUCTS, INC.FHG2023-02-27
00840113231607PlastiBell Circumcision DeviceASPEN SURGICAL PRODUCTS, INC.FHG2023-02-27
00840113231614PlastiBell Circumcision DeviceASPEN SURGICAL PRODUCTS, INC.FHG2023-02-27
00840113231621PlastiBell Circumcision DeviceASPEN SURGICAL PRODUCTS, INC.FHG2023-02-27
00840113231638PlastiBell Circumcision DeviceASPEN SURGICAL PRODUCTS, INC.FHG2023-02-27
00840113231645PlastiBell Circumcision DeviceASPEN SURGICAL PRODUCTS, INC.FHG2023-02-27
00840113231652PlastiBell Circumcision DeviceASPEN SURGICAL PRODUCTS, INC.FHG2023-02-27
00840113231669PlastiBell Circumcision DeviceASPEN SURGICAL PRODUCTS, INC.FHG2023-02-27
10767056092171MABIS DMID-M-S HOLDINGS, INC.FHG2016-09-23
10767056092300MABIS DMID-M-S HOLDINGS, INC.FHG2016-09-23
10767056092324MABIS DMID-M-S HOLDINGS, INC.FHG2016-09-23
10767056092331MABIS DMID-M-S HOLDINGS, INC.FHG2016-09-23
10767056092348MABIS DMID-M-S HOLDINGS, INC.FHG2016-09-23
10767056092355MABIS DMID-M-S HOLDINGS, INC.FHG2016-09-23
10767056092379MABIS DMID-M-S HOLDINGS, INC.FHG2016-09-23
10767056092157MABIS DMID-M-S HOLDINGS, INC.FHG2016-09-23
10767056092317MABIS DMID-M-S HOLDINGS, INC.FHG2016-09-23
10767056092102MABIS DMID-M-S HOLDINGS, INC.FHG2016-09-23
10767056092119MABIS DMID-M-S HOLDINGS, INC.FHG2016-09-23
10767056092126MABIS DMID-M-S HOLDINGS, INC.FHG2016-09-23
10767056092133MABIS DMID-M-S HOLDINGS, INC.FHG2016-09-23
10767056092140MABIS DMID-M-S HOLDINGS, INC.FHG2016-09-23
10653160274766CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFHG2016-09-10
10653160274810CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFHG2016-09-10
10653160274759CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFHG2016-09-07