FDA.reportPublic FDA data

Mystic

Primary DI
00888937003116
Brand
Mystic
Company
Coopersurgical, Inc.
Model
10058
Device description
Mystic® II MitySoft® Bell Cup Vacuum-Assist Delivery System
Published
2016-08-16
Public version status
Update
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
HDBExtractor, Vacuum, Fetal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDBExtractor, Vacuum, FetalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011532000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011532000MITYVACPrism Enterprises, Inc.2001-07-30HDB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888937003110PackageGS112In Commercial Distribution
30888937003117PackageGS12In Commercial Distribution
00888937003116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088893700311020888937003110
3088893700311730888937003117
00888937003116008889370031168889370031160888937003116

GMDN Terms#

Term, Definition table
TermDefinition
Foetal vacuum extraction system, manual, single-useAn assembly of hand-operated devices designed to facilitate the delivery of a foetus during vaginal childbirth or Caesarean section by enabling traction to be applied to the foetal head by means of a suction cup that is attached to the scalp. It typically consists of a cup with a soft inner liner to prevent tissue damage, a hand-operated pump, and a handle used to apply traction. It is typically used for dystocia, uterine inertia, maternal exhaustion, maternal/foetal distress. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
801895244
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888937032833LifeGlobal® Coda®Incubator UnitGCIU-010-M2026-08-03
00888937032840LifeGlobal® Coda®Filter for Incubator UnitGCIF-001-M2026-08-03
00888937032871LifeGlobal® Coda®Incubator UnitC2IU-010-M2026-08-03
00888937032901LifeGlobal® Coda®Inline® Filter: PurpleCIPR-001-M2026-08-03
00888937032918LifeGlobal® Coda®Inline® Filter: GreenCXGR-001-M2026-08-03
00888937033915ORIGIOl®Gas Line FilterULTRA-001-M2026-08-03
20888937000027Her OptionCU-12014-09-17
00888937033687ONETRACC1001502026-07-10
00888937033694ONETRACC1001652026-07-10
00888937033700ONETRACC1001702026-07-10
00888937033717ONETRACC1001802026-07-10
00888937033724ONETRACC1001902026-07-10
00888937033731ONETRAC LXC1002102026-07-10
00888937033748ONETRAC LXC1002202026-07-10
00888937033755ONETRAC LXC1002302026-07-10
00888937033762ONETRAC LXC1002402026-07-10
00888937033779ONETRAC LXC1002502026-07-10
00888937033786ONETRAC™ LXSC1002602026-07-10
00888937033793ONETRAC™ LXSC1002702026-07-10
00888937033809ONETRAC™ LXSC1002802026-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814247021243Kiwi® OmniCup®CLINICAL INNOVATIONS, LLCHDB2025-12-16
07612367000109Silicone tubing ID 6.5mm, 180cm, 1 coupling pieceMedela AGHDB2024-05-31
07612367003551Quiver 280mmMedela AGHDB2024-05-31
07612367003568Quiver 480mmMedela AGHDB2024-05-31
07612367003575Change over valveMedela AGHDB2024-05-31
07612367003698Overflow protection deviceMedela AGHDB2024-05-31
07612367003735Reusable serial connectorMedela AGHDB2024-05-31
07612367003742Safety Set for railholderMedela AGHDB2024-05-31
07612367003896Tubing holder left sideMedela AGHDB2024-05-31
07612367003902Tubing holder right sideMedela AGHDB2024-05-31
07612367004275Silicone tube, ID 7mm, 100cmMedela AGHDB2024-05-31
07612367004688Holder for 1L/1.5L jar, leftMedela AGHDB2024-05-31
07612367004695Holder for 1L/1.5L jar, rightMedela AGHDB2024-05-31
07612367004701Holder for 2L/2.5L jar, leftMedela AGHDB2024-05-31
07612367004718Holder for 2L/2.5L jar, rightMedela AGHDB2024-05-31
07612367008242Double conical coupling pieceMedela AGHDB2024-05-31
07612367008655Silicone tube, ID 7mm, 33cmMedela AGHDB2024-05-31
07612367009928Y-pieceMedela AGHDB2024-05-31
07612367011204Vario Filter set, bacteria & overflowMedela AGHDB2024-05-31
07612367011372Single set 1lMedela AGHDB2024-05-31
07612367011389Single set 2lMedela AGHDB2024-05-31
07612367011600Single set 2l, clampholderMedela AGHDB2024-05-31
07612367017329Single set 1l, clampholderMedela AGHDB2024-05-31
07612367017336Single set 3l, clampholderMedela AGHDB2024-05-31
07612367017343Single set 5l, clampholderMedela AGHDB2024-05-31
07612367017350Double set 3lMedela AGHDB2024-05-31
07612367017367Double set 5lMedela AGHDB2024-05-31
07612367038225Double set 2lMedela AGHDB2024-05-31
07612367047692Trolley A for DCSMedela AGHDB2024-05-31
07612367051033Trolley B for DCSMedela AGHDB2024-05-31