FDA.report

Black & Black Surgical

Primary DI
00840329829445
Brand
Black & Black Surgical
Company
BLACK & BLACK SURGICAL, INC.
Model
B95850
Catalog number
B95850
Device description
PRATT UTER DILATOR DE 29-31FR
Published
2023-05-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GCCDilator, catheter

Product Code Classifications

CodeDeviceSpecialtyClass
GCCDilator, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840329829445PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840329829445008403298294458403298294450840329829445

GMDN Terms

TermDefinition
Urethral sound, reusableA hand-held manual surgical instrument designed to explore and measure the urethra. It is a slender hollow or solid cylindrical instrument made of metal or plastic typically with graduations of length displayed along its working end. It is typically available in a range of sizes and flexibilities. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(770)414-4880info@blackandblacksurgical.com

Regulatory Flags

DUNS number
004382282
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00840329836924Black & Black SurgicalB60039B600392026-03-05
00840329837457N/AB80050B800502026-03-05
00840329837464N/AB80051B800512026-03-04
00840329836795N/AB8XFIC-V-CC1218-LLB8XFIC-V-CC1218-LL2026-01-16
00840329837013N/AB8XIII-526L-AHB8XIII-526L-AH2026-01-16
00840329836375N/AB8XLVH-640L-AHB8XLVH-640L-AH2026-01-15
00840329836382N/AB8BX-DBAS-523 PWRB8BX-DBAS-523 PWR2026-01-15
00840329836399N/AB8BX-DBAS-530 PWRB8BX-DBAS-530 PWR2026-01-15
00840329836405N/AB8BX-DMER-523 PWRB8BX-DMER-523 PWR2026-01-15
00840329836412N/AB8XDBAS-530LB8XDBAS-530L2026-01-15
00840329836429N/AB8XSPA-1120-LLB8XSPA-1120-LL2026-01-15
00840329836443N/AB8XFAN-149-LLB8XFAN-149-LL2026-01-15
00840329836450N/AB8BX-BAS-432 PWR BARBB8BX-BAS-432 PWR BARB2026-01-15
00840329836467N/AB8XFIC-I-CC1810-LLB8XFIC-I-CC1810-LL2026-01-15
00840329836474N/AB8XSPA-CC1810-LLB8XSPA-CC1810-LL2026-01-15
00840329836481N/AB8XMLV-1215-LLB8XMLV-1215-LL2026-01-15
00840329836498N/AB8AX-MIII-432 MLRB8AX-MIII-432 MLR2026-01-15
00840329836504N/AB8XMER-215-SHB8XMER-215-SH2026-01-15
00840329836542N/AB8BX-BAS-540 ANG PWRB8BX-BAS-540 ANG PWR2026-01-15
00840329836559BLACK & BLACK SURGICAL, INC.B8BX-III-432 PWR RTB8BX-III-432 PWR RT2026-01-15

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00842331192708Novo Surgical IncNOVO SURGICAL, INC.GCC2023-08-14
00842962125571HNM MEDICALHNM STAINLESS, LLC.GCC2023-04-03
00842962125526HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-29
00842962125533HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-29
00842962125540HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-29
00842962125557HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-29
00842962125564HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-29
00842962124345HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-23
00842962124352HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-23
00842962124369HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-23
00842962124376HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-23
00842962124383HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-23
00842962124390HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-23
00842962124406HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-23